- 1) The careful assessment of interactions between drug products and their container closure systems and manufacturing process contact material is crucial for the compliance and safety of pharmaceutical and biopharmaceutical products. It is imperative that each drug application filing provides comprehensive data to prove the safety and suitability of the proposed container closure systems for their intended use.
- 2) As per cGMP regulatory requirements (21 CFR Part 211.94 (a)), drug product containers and closures must not be reactive, additive, or absorptive in a way that would change the safety, identity, strength, quality, or purity beyond the official or established requirements. This underscores the need to assess drug products for potential chemical contaminants or impurities that could arise during manufacturing or storage, a process carried out through extractable and leachable studies.
- 3) Drawing on over three decades of experience in E&L testing, VIMTA stands as a pioneering and highly preferred testing partner in this specialized field. Our cutting-edge laboratories are furnished with LCMS/MS, GCMS, and ICPMS technologies, enabling precise identification of chemical compounds that may leach from the product during usage. At Intervein, we provide tailored protocol-driven E&L testing services to help guarantee that your product complies with relevant regulatory requirements and is safe for patients. Our adept scientific team has conducted over 2000 E&L studies across various product categories and possesses comprehensive knowledge of applicable standards and regulatory stipulations. The data from our studies has been submitted to, and well received by, US and European regulatory authorities.
Furthermore, our packaging material expertise covers an array of components, including:
- 1) – Rubber stoppers – EPDM packaging
- 2) – Gaskets & O-rings – Inhalation devices
- 3) – Prefilled syringes – Glass vials
- 4) – Syringes – Resins
- 5) – Injectable bags/vials – Films, blister packs
- 6) – Laminated tubes – Tubing & filters
- 7) – Large volume containers – Disposables (Bioprocess – single use)
- 8) – HDPE, LDPE, PP, Plastic bags & containers – In-process manufacturing components
- Our product experience includes but is not limited to:
- 1) Inhalations
- 2) Ophthalmic
- 3) Parenteral, Injectables
- 4) Oral vaccines
- 5) Topicals
- 6) Dermal Patches
- 7) Implants
- 8) Solid dosage forms